Generic Launches

Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date

Summer 2014

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Taclonex	Leo Pharma	Calcipotriene / Betamethasone Dipropionate Ointment	Sandoz	Topical treatment of psoriasis vulgaris	4/1/2014
Taclonex	Leo Pharma	Calcipotriene / Betamethasone Dipropionate Ointment	Perrigo	Topical treatment of psoriasis vulgaris	4/1/2014
Ten-K	Novartis	Potassium Chloride Extended-release Capsules	Par Pharm	Hypokalemia with or without metabolic alkalosis, in digitalis intoxications, hypokalemic familial periodic paralysis	4/7/2014
Lovaza	GlaxoSmithKline	Omega-3-Acid Ethyl Esters Capsules, USP	Teva	Adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia	4/8/2014
Lunesta	Sunovion Pharms	Eszopiclone Tablets	Dr. Reddy's Labs	Insomnia	4/15/2014
Lunesta	Sunovion Pharms	Eszopiclone Tablets	Mylan	Insomnia	4/15/2014
Lunesta	Sunovion Pharms	Eszopiclone Tablets	Teva	Insomnia	4/15/2014
Lunesta	Sunovion Pharms	Eszopiclone Tablets	Glenmark Generics	Insomnia	4/15/2014
Ortho Evra	Janssen Pharms	Norelgestromin / Ethinyl Estradiol Transdermal System	Mylan	Prevention of pregnancy	4/16/2014
Antara	Lupin	Fenofibrate Capsules	Dr. Reddy's Labs	Cholesterol	4/23/2014
Differin	Galderma Labs	Adapalene gel	Sandoz	Topical treatment of acne vulgaris in patients 12 years of age and older	4/28/2014
Catapres-TTS	Boehringer Ingelheim	Clonidine Transdermal System	Actavis	Hypertension	5/7/2014
Astepro	Media Pharms	Azelastine hydrochloride nasal spray (0.15%)	Perrigo / Impax Labs	Nasal symptoms caused by seasonal allergies or environmental irritants	5/12/2014
Exalgo	Mallinckrodt	Hydromorphone Hydrochloride Extended-release Tablets	Actavis	Moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time	5/13/2014
Zyprexa Zydis	Eli Lilly	Olanzapine Orally Disintegrating Tablets	Mylan	Schizophrenia or the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder	5/14/2014
Malarone	GlaxoSmithKline	Atovaquone / Proguanil Hydrochloride	Mylan	Prophylaxis of plasmodium falciparum malaria and the treatment of acute, uncomplicated P. falciparum malaria	5/29/2014
Paraplatin	Bristol-Myers Squibb	Carboplatin Injection	Mylan	Advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents	6/9/2014
Actonel	Warner Chilcott	Risedronate Sodium Tablets	Mylan	Osteoporosis in postmenopausal women	6/11/2014
Cipro	Bayer Healthcare	Ciprofloxacin for Oral Suspension	Lupin Pharms	Infections caused by susceptible isolates of the designated microorganisms in various conditions and patient populations	6/13/2014